Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment (BCD)

Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment

This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.

It could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Device: Xrays; Device: Ultrasound (B mode ); Device: Ultrasound (D mode)

Detailed Description

The aim of this study is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of patients affected by rheumatoid arthritis (ACR/EULAR 2010). The first approach is the assessment of remission defined by modified SDAI in order to evaluate in all cases the same number of joints [Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and and practitioner with VAS, and PCR ≤ 3.3mg/l] (mode C). The second one is a combined approach: clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B). The last one is an ultrasound approach (remission defined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).

This trial is a National randomized multicentre trial that compares three modes of follow to adjust the therapeutic adaptation in Rheumatoid Artritis.

• Study Type: Interventional
• Enrollment (Actual): 561
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers
  • Brest, France, 29609
    • CHRU Brest
  • La Roche sur Yon, France, 85925
    • CHU La Roche sur Yon
  • Le Mans, France, 72037
    • CH Le mans
  • Lorient, France, 56322
    • CH de Lorient
  • Nantes, France, 44093
    • CHU Nantes
  • Orléans, France, 45067
    • CHR Orléans
  • Rennes, France, 35203
    • CHU SUD Rennes
  • Tours, France, 37044
    • CHU Tours
  • Vannes, France, 56017
    • CH Vannes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  • Both gender patients aged 18 -to 80 years old
  • Patients will be eligible if they fulfill ACR/EULAR 2010 rheumatoid arthritis
  • All the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, ARAVA or biologics treatment: Enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion
  • Patients would be able to understand and be agree with the protocole
  • Patients would be able to consent

• Exclusion Criteria:

  • Patient unable to cooperate patient and who refuse to sign consent form
  • Patient unable to understand the study,under administrative supervision or legal guardianship
  • Signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral
  • Scheduled surgery procedure during the study on the estimated joint.
  • Patient non-affiliated to social security
  • Pregnant and nursing mothers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm C (Clinical); No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation.	Device: Xrays; Clinical evaluation
Other: Arm B (Clinical + Ultrasound); No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode).	Device: Xrays; Clinical evaluation; Device: Ultrasound (B mode )
Other: Arm D (Ultrasound); No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode.	Device: Ultrasound (D mode)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.	The primary outcome is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of rheumatoid arthritis patients (ACR/EULAR 2010) according to remission defined by modified SDAI in order to evaluate in all cases the same number of joints [Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and practitioner with VAS, and PCR ≤ 3.3mg/l] (mode C), with a combined approach clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B) or an ultrasound approach (remission défined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the proportion of rheumatoid arthristis in remission according to the method used	at 3 month, 6 month, 9 month and 1 year
Assessement of the Xrays evolution at 2 years	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2015
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimated): April 7, 2015

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis / ultrasonography / synovitis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: BCD 29BRC14.0097